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Pneumatherm

by National Pain Institute

510(k) K922089

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK922089 Date23 Feb 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IRT
Device Class
Class II
Regulation
21 CFR Part 890.5740
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Pneumatherm is a medical device identified under product code IRT. It is designed for use within the field of physical medicine.

This device received FDA 510(k) clearance on February 23, 1993, under the reference number K922089. It is manufactured by the National Pain Institute.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of the Pneumatherm device?

    The Pneumatherm is a medical device specifically designed for applications within the field of physical medicine. It is categorized under product code IRT.

  • What is the regulatory status of the Pneumatherm?

    The Pneumatherm received FDA 510(k) clearance on February 23, 1993. This clearance was granted under the reference number K922089 after the device was determined to be substantially equivalent to existing devices.

  • Who is the manufacturer of the Pneumatherm?

    The Pneumatherm is manufactured by the National Pain Institute, located in Huntington Beach, California. The company submitted the device for review, which resulted in its clearance in 1993.